Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018889
Company: ABBOTT
Company: ABBOTT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METRONIDAZOLE | METRONIDAZOLE | 500MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/18/1983 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/20/1996 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/23/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 11/20/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/17/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/03/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/24/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |